Farmingdale, NY, United States
Syntho Pharmaceuticals, Inc. recalls
1 recall recorded since 2018, most recently on 17 April 2017. None are listed as ongoing. Status and classification are as published by the FDA.
Recalls1
Ongoing (FDA)0
Terminated or completed1
Class I (FDA)0
Terminated Class II Drugs
- Recall started
- 17 April 2017
- Terminated
- 27 March 2020
- Reason
- CGMP deviations: Lots were recalled due to sub-potency and cGMP violations.
- Distribution
- Product was sold to the firm's sole distributor who further distributed the product throughout the United States.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- D-0377-2019, D-0378-2019
- EEMT HS (esterified estrogens and methyltestosterone) 0.625 mg/1.25 mg, tablets,100-count bottle, Rx only, Manufactured By: Syntho Pharmaceuticals, Inc., Farmingdale, NY 11735, Distributed By: Creekwood Pharmaceutical, I
- EEMT (esterified estrogens and methyltestosterone) 1.25 mg/2.5 mg, tablets,100-count bottle, Rx only, Manufactured By: Syntho Pharmaceuticals, Inc., Farmingdale, NY 11735, Distributed By: Creekwood Pharmaceutical, Inc.,
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.